Mentor eirb Researcher User Manual

Ascension Wisconsin IRB Mentor eirb Researcher User Manual Contents 1 Introduction 1.1 Purpose of this Manual 1.2 User Support 2 Mentor eirb & User Accounts 2.1 About Mentor 2.2 User Roles 2.3 Requesting a User Account 3 General Tips & How-Tos 3.1 Logging in 3.2 Resetting your password 3.3 Navigation and Important Pages 3.4 Designating a Research Coordinator 3.5 Bookmarked Pages 3.6 File Management 3.7 Mentor Messages 4 Submissions 4.1 New Studies 4.2 Continuing or Final Reports 4.3 Amendments 4.4 Reportable Events 4.5 Acknowledgement of Other Materials 4.6 Humanitarian Use Devices 4.7 Request to Defer to NCI CIRB or other Single IRB Reliance Request AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 1 of 22

1 Introduction 1.1 1.2 Purpose of this Manual This manual provides essential information that Researchers need to use Mentor eirb. The manual includes a description of the Mentor system and step-by-step explanation of common uses. User Support Mentor System Help To access the Mentor System help text, click on this red question mark icon: You will see this icon and other red color icons or text through Mentor. You can interact with the red items for more information usually you hover over them or click them. Training and Assistance You can contact IRB staff anytime during normal business hours for assistance using Mentor or to schedule a training session. Refer to the IRB website for current contact information. 2 Mentor eirb & User Accounts 2.1 2.2 About Mentor Mentor is an electronic IRB submission and document management system. All submissions to the IRB are submitted using Mentor. Mentor is online and available from any device with internet access. IRB submission forms and templates, including consent form templates, are located on the IRB Info page in Mentor. User Roles The role titles in Mentor are based on the privileges each role has in the system. The role assignment or titles of research personnel in Mentor may be different from that on the Site Delegation of Authority Log or other study documentation. The Mentor Protocol application requires individuals to be identified as one of the following roles: PI: This is the Principal Investigator, as defined above. All approval notices, expiration reminders and other announcements and notifications from Mentor will be sent to the PI. External PI: The designation should be used when the PI is someone external to Ascension Wisconsin with no formal affiliation to the institution. This person would have the research personnel role of Co-I or Sub-I. If added as an External PI in Mentor, they will not be able to access Mentor at all; if they require access, they could request a Mentor user account. Sub-I: The Sub-I role in Mentor should include all Sub-I s and Co-I s as defined above. Persons assigned to this role will have access to view all information in Mentor, but will not receive notifications and are not able to submit and manage protocols. Research Coordinator: Principal investigators may designate one or more other Mentor users as Research Coordinators. Research coordinators are authorized to submit and manage protocols on behalf of their PI. They will also receive all approval notices, expiration reminders and other announcements and notifications from Mentor that are sent to the PI. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 2 of 22

Research Associate: Any other study staff should be identified in Mentor as a research associate. Research associates have access to view all information in Mentor, but will not receive notifications and are not able to submit and manage protocols. 2.3 Requesting a User Account You must have a Mentor account before you can access Mentor. Additionally, before staff can be added to a study, they must also have an account. There are two steps in creating an account. STEP 1: Create a New Mentor Account 1. You will need the Form Code: 2. Go to: https://www.axiommentor.com/free/system/newaccount.cfm 3. Complete and submit the form. 4. You will get an email to confirm your email address and set your password. You can only set up an account online using this method if you use an email address from Ascension Wisconsin or common research affiliates (email addresses such as Gmail won't work). If you do not meet these criteria you must contact IRB staff to request an account. STEP 2: Complete your User Profile Once you have a Mentor account, there may be additional steps you need to complete before submitting a project through Mentor. Your User Profile will depend on the kinds of projects that you will submit for review. Involved in the conduct of human subject research CV/ Resume CITI Training Humanitarian Use Devices (HUD) X X Only non-human subject research proposals (like Quality Improvement projects and Emergency or Expanded Access to an investigational product.) Students, residents and fellows conducting research Conflict of Interest Training/ Disclosure X X X Advisor has/will create account X X X X To upload the required documents: 1. Log into Mentor 2. Go to the IRB tab across the top 3. Click on My Training Certificate along the right 4. Use the grey upload button to upload the documents AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 3 of 22

3 General Tips & How-Tos 3.1 Logging in You will get an automated email from Mentor when your account is established providing instructions. In order to login to the Mentor IRB system the first time, you must set a password. 1. Go to the Mentor website. This link is also found on the IRB public web site. 2. The Institution ID is ASCENSION. Click the box below that field so the Institution ID is filled in every time you visit the Mentor site. 3. The User ID field is your email address. This is the email you requested when you opened the account. For most Ascension Associates and employed physicians this will be the Ascension email address. It will also be the same as the email you use for COI SMART. Non- Ascension researchers should enter the email address listed on the IRB application form. 4. Enter the password that you chose when you logged in for the first time. 3.2 Resetting your password Go to the Mentor website and choose the "Forgot Password" link just below the login fields. Follow the instructions in the reset your password section above. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 4 of 22

3.3 Navigation and Important Pages Mentor Home Page You will be taken to this page when you first log in. Click the IRB tab to get to the IRB forms and other functions. *If there are announcements, they will be displayed here IRB Info Page After clicking the IRB tab, you will be taken to the IRB Info page that lists all IRB submission forms. IRB forms- click the red link to download the document My Protocols Page From this page you can: - Create a new protocol - See all studies that you are listed on and filter by type of study, or your role on the study - Click the study title (red link) to go to the study page - Quickly see the study status, if revisions have been requested and the date the next annual review is due. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 5 of 22

Protocol Main Page Each protocol has a main page that lists the general information about the protocol. These fields are completed at the time of initial submission. The main parts of that page are noted below: Protocol title Study team Review type and approval/ expiration dates General study questions Questions depending on the kind of review requested Documents uploaded with the initial review Current approved documents Tabs for ongoing submissions (Cont. Review, Amendments, deviations, etc.) AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 6 of 22

3.4 Designating a Research Coordinator Research Coordinators identified in Mentor are able to complete and submit to the IRB on behalf of the PI. However, the PI must designate a coordinator in order for the Research Coordinator field to appear on the PI's protocol summary. Only the names of Research Coordinators who are designated to the PI will be able to selected on that PIs studies. If the PI is unable to do this, contact the IRB office. To designate a Research Coordinator the PI must: 1. Log into Mentor eirb and go to Research Coordinators on the left navigation bar. 2. Click the Designate a New Research Coordinator button. 3. Start typing the coordinator s last name. If the coordinator has a Mentor eirb account, their name will appear. Choose the name and click Designate. If the coordinator does not have a Mentor account yet, they must request one. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 7 of 22

4. The Research Coordinator s name will now appear on the PI s Research Coordinator page. *Designated Research Coordinators names are listed here The designated Research Coordinator s name will also show up as an option in the Research Coordinator field when creating a new protocol for that PI. Selecting a Research Coordinator here assigns the coordaintor to a specific study. 3.5 Bookmarked Pages The Mentor Home page includes a My Bookmarks link so that you can have quick access to pages that you commonly use. To bookmark a page, you can click on this red B icon at the top right corner of each page: AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 8 of 22

3.6 File Management Before any submission is approved by the IRB, the PI or coordinator are able to click on the red page icon next to the file name to edit, replace or delete the document. To do this: 1. Navigate to the submission in Mentor. 2. Left click on the red page icon that is to the left of the file name link. 3. Choose the option. Edit= rename or change file type Replace= submit a new version of a document already uploaded to Mentor, you should replace the file NOT upload a second one Versions= see all uploaded versions Delete= remove the document from Mentor 4. Follow the instructions on each step to complete the selection. 3.7 Mentor Messages The study team, IRB staff and IRB members can all send messages through Mentor. There is a Messages link at the top right corner of every submission section. On the Message page, you will be able to create a new massage, view and respond to any past messages. When a new message is sent, the recipient receives the message via their email account. You can respond via email, and all messages are stored in the appropriate section in Mentor for documentation. However, you CANNOT include attachments to Mentor messages, they are not sent. You must upload any documents directly into Mentor. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 9 of 22

4 Submissions 4.1 New Study Creating a new protocol in Mentor 1. After logging into Mentor, all of the IRB forms are located on the IRB info page. 2. Make sure to have the materials completed as outlined in IRB Submission Guide for Expedited or Full IRB Review or Exempt studies. Go to the My Protocols page and click on the Create New Protocol button. 3. A Protocol Summary page will open. Complete the questions. a. Research Personnel Researchers must have a Mentor eirb account in order to be added to a study. To request an account go to the Mentor eirb page on the IRB website. Once a Mentor account is set up, you can type last name of the individual and Mentor will populate the field. i. Principal Investigator: Choose the PI name from the drop-down menu. ii. Research Coordinator: If the PI has designated research coordinators, a Research Coordinator field will appear. Choose the Research Coordinator s name from the drop-down menu. The Research Coordinator will be copied on all eirb correspondence sent to the PI. Instructions for designating a Coordinator are on the IRB website. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 10 of 22

iii. Sub-I: Type the first few letters of the individual s last name. Choose the name from the list and click Add. These people will have view only privileges. iv. External PIs: Do not add research collaborators at other sites unless they are engaged in the conduct of the research at the institution. If you have a question about engagement contact the IRB staff at IRB@ascension.org or 414-465-3059. v. Research Associate: Type the first few letters of the individual s last name. Choose the name from the list and click Add. These people will have view only privileges. b. Protocol title Enter the protocol title. c. Start and End dates Enter the anticipated Start and End dates; start date is required. d. Sponsor information Select the Sponsor Funding type and, if appropriate, enter the study Sponsor/Funding agency and Sponsor or grant study ID. e. Review Type Different questions appear based on the review type you select. i. Full Review: Studies greater than minimal risk ii. Exemption Requested: Human subject research that meets the an exemption category or projects that are not research or do not include human subjects iii. Expedited Review Requested: Studies that are no greater than minimal risk iv. Delegate to and External IRB: Studies requesting another IRB complete the review v. Humanitarian Use Device Request: HUD protocols vi. Emergency Use: Emergency use of an investigational product f. Complete review type specific questions Different questions appear based on the review type you select. g. Upload the Protocol and Main Consent form- you can upload other documents later h. Message If desired, you can send a message to the IRB staff/chair i. Save the Completed Protocol Summary. Click Save when the summary is complete. After saving, an Upload Documents button will appear on the top of the protocol summary. 4. Once saved, you will then be taken to the protocol main page, where you can upload any additional documents. Click on the Upload Docs button at the top of the page. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 11 of 22

In Upload Documents pop up, choose a file type from the drop down menu (IRB application, questionnaire, advertisement, additional consent, etc.). Repeat this to attach and save all applicable items. 5. The uploaded documents will automatically appear at the bottom of the protocol summary under a header that matchers the chosen file type name. 6. Your submission IS NOT complete unless you click the Submit Protocol for Review button at the top of the main protocol page. 7. Once you click this to submit the protocol, the IRB staff is notified of the submission and will contact you with any questions. If the IRB requests modifications AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 12 of 22

The PI and Research Coordinator will receive an email notification if there are questions about your application or revision requests. Follow the steps below to submit revised documents. 1. Log into Mentor and go to the My Protocols page and click on the study title. This takes you to the Protocol Summary page. 2. All of the documents uploaded for the new study are towards the bottom of the page. 3. To replace a document with a revised version, first make sure the revised version has been saved to your PC. Then click on the icon next to the current document, and choose Replace. IRB staff will receive notice that a revised document has been submitted. Follow the steps below to submit additional documents 1. Log into Mentor and go to the My Protocols page and click on the study title. This takes you to the Protocol Summary page. 2. There are gray buttons on top of the Protocol Summary page. To upload a new document, click the Upload Docs button. 3. Choose the file type that best describes the document. Click Browse to add the file and Save to notify IRB staff that a new document has been submitted. 4. The document will appear at the bottom of the protocol summary under a header that matchers the chosen file type name. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 13 of 22

4.2 Continuing or Final Reports 1. Go to the Mentor eirb Info Page download the current Continuing or Final report form. Complete the form and gather other necessary documents indicated in the form. Save all documents as separate electronic files on your computer. 2. When you are ready to submit the continuing or final report, click on "My Protocols" and choose the study. Scroll down to the bottom of the page and click on the "Cont. Reviews" tab. 3. The first item listed should be the report with the Status "Due". Click on the icon, select "Edit". AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 14 of 22

4. On the Cont. Review page, indicate the current enrollment status of the study and upload any related documents. You can also enter a note for the IRB staff. Click Submit Report. 5. Your submission is complete, and an IRB staff member will contact you with any questions. Continuing or Final Report IRB revision requests The PI and Research Coordinator will receive an email notification if there are questions or revision requests. To submit new or revised documents in the Cont. Review workspace: 1. Locate the study on the My Protocols page and click on the study title. This takes you to the Protocol Summary page. 2. Scroll down to the bottom of the page and click on the Cont. Review tab. Locate the report you are working on (most recent will be on the top). 3. Left click the icon and choose Upload or Replace. Upload the new or revised document(s). Make sure the document is saved with the title you want to display in Mentor eirb. IRB Staff will receive notice that a new/revised document has been submitted. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 15 of 22

4.3 Amendments 1. Go to the Mentor eirb Info Page download the current Amendment form. Complete the form and gather other necessary documents indicated in the form. Save all documents as separate electronic files on your computer. 2. When you are ready to submit the Amendment, click on "My Protocols" and choose the study. Scroll down to the bottom of the page and click on the "Amendments" tab, then click the Upload New Amendment. 3. On the Amendment page, upload the completed amendment form and any related documents. You can also enter a note for the IRB staff. Click "Save" to submit. 4. Your submission is complete, and an IRB staff member will contact you with any questions. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 16 of 22

Amendment IRB revision requests The PI and Research Coordinator will receive an email notification if there are questions or revision requests. To submit new or revised documents in the Amendment workspace: 1. Locate the study on the My Protocols page and click on the study title. This takes you to the Protocol Summary page. 2. Scroll down to the bottom of the page and click on the Amendments tab. Locate the report you are working on (most recent will be on the top). 3. Left click the icon and choose Upload or Replace. Upload the new or revised document(s). Make sure the document is saved with the title you want to display in Mentor eirb. IRB Staff will receive notice that a new/revised document has been submitted. IRB revision requests 4.4 Reportable Events 1. Go to the Mentor IRB info page and download and complete the appropriate form. Save the form and any supporting documents as separate electronic files on your computer. 2. When you re ready to submit the Unanticipated Problem Report, Significant Deviation/Noncompliance Report, or Safety Update (new information from Sponsor, FDA, or DSMB), go to My Protocols and click on the title of the study. Scroll down to the bottom of the page and click the applicable reportable event tab (Unanticipated Problem, Deviation, or Safety Update). Then, use the button to create a new submission. 3. A report information box will open. Attach the report form and check boxes relevant to the submission. Click Save to submit the report. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 17 of 22

4. To upload additional document, go to the submission and click on the icon to upload additional documents (revised IB, IND safety report, DSMB report, etc.). 5. Your submission is complete, and an IRB staff member will contact you with any questions. 4.5 Acknowledgement of Other Materials 1. If the study team or study Sponsor want to inform the IRB about something that does not meet the criteria of other submission, you can use the Administrative Review section. Go to "My Protocols" and click on the title of the study. Scroll down to the bottom of the page to the Administrative Review tab, and click New Item AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 18 of 22

2. On the Administrative review page, upload the file and enter a brief description. Then, click Save. 3. To upload additional document, go to the submission and click on the icon to upload additional documents related to the administrative review. 4.6 Humanitarian Use Devices 1. Go to the Mentor IRB info page and download and complete the HUD form. Save the form and any supporting documents as separate electronic files on your computer. 2. After completing and organizing materials as outlined in the HUD Instructions & Application Form, you are ready to submit the study in Mentor eirb. Go to the My Protocols page and click the Create New Protocol button. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 19 of 22

3. A Protocol Summary page will open. Answer the Protocol Summary questions. Some specific guidance is provided here. a. Adding Physicians to a HUD: Physicians must have a Mentor eirb account in order to be added to a new HUD protocol. b. Review Type: Choose HUD c. Upload HUD product brochure and Patient Information Booklet (or consent if applicable): These documents can be uploaded at the bottom of the survey. Other documents can be uploaded later. Click "Save" when the survey is complete. 4. Click the Upload Documents Button. In Upload Documents, choose a file type from the drop down menu and attach all applicable items. The uploaded documents will automatically appear at the bottom of the Protocol Summary. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 20 of 22

5. Your submission IS NOT complete unless you click the Submit Protocol for Review button at the top of the main protocol page. 6. Once you click this to submit the protocol, the IRB staff is notified of the submission and will contact you with any questions. Humanitarian Use Device Continuing Review 1. Locate the HUD Continuing Report form on the Mentor Info Page. 2. After completing and organizing materials as outlined in the HUD Continuing Report Form, follow steps for the standard Continuing or Final Report submission. 4.7 Request to Defer to NCI CIRB or other Single IRB Reliance Request 1. Go to the Mentor IRB info page and download and complete the appropriate form. Save the form and any supporting documents as separate electronic files on your computer. 2. Follow the instructions for a submitting a New Study, with the special considerations below. 3. If you are requesting to rely on an external IRB (including NCI CIRB) select the review type Delegate to an External IRB. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 21 of 22

4. If you are requesting for our IRB to be the single IRB of record, select the appropriate review type and make sure to complete the following question during the submission. AW-IRB-Mentor_ResearcherManual_v.08/15/17 Page 22 of 22